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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
AstraZeneca
Johnson and Johnson
UBS
Daiichi Sankyo
US Army
Mallinckrodt
Healthtrust
McKesson

Generated: December 12, 2017

DrugPatentWatch Database Preview

GLAXOSMITHKLINE Company Profile

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What is the competitive landscape for GLAXOSMITHKLINE, and what generic alternatives to GLAXOSMITHKLINE drugs are available?

GLAXOSMITHKLINE has one hundred and sixty approved drugs.

There are sixty-two US patents protecting GLAXOSMITHKLINE drugs.

There are one thousand one hundred and sixty-three patent family members on GLAXOSMITHKLINE drugs in seventy-one countries and one hundred supplementary protection certificates in fifteen countries.

Summary for GLAXOSMITHKLINE

International Patents:1163
US Patents:62
Tradenames:114
Ingredients:96
NDAs:160
Drug Master File Entries: 8
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxosmithkline ConsFLONASE SENSIMIST ALLERGY RELIEFfluticasone furoateSPRAY, METERED;NASAL022051-002Aug 2, 2016OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
GlaxosmithklineVENTOLINalbuterol sulfateTABLET;ORAL019112-001Jul 10, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-004Jun 13, 2008ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
GlaxosmithklinePYOPENcarbenicillin disodiumINJECTABLE;INJECTION050298-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
GlaxosmithklineBACTOCILLoxacillin sodiumCAPSULE;ORAL062241-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Glaxosmithkline ConsFLONASE SENSIMIST ALLERGY RELIEFfluticasone furoateSPRAY, METERED;NASAL022051-002Aug 2, 2016OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
GlaxosmithklineNICORETTEnicotine polacrilexGUM, CHEWING;BUCCAL020066-004Sep 25, 2000OTCYesNo► Subscribe► Subscribe► Subscribe► Subscribe
GlaxosmithklineANTEPARpiperazine citrateTABLET;ORAL009102-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
GlaxosmithklineTRELEGY ELLIPTAfluticasone furoate; umeclidinium bromide; vilanterol trifenatatePOWDER;INHALATION209482-001Sep 18, 2017RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Glaxosmithkline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-002Sep 20, 1995► Subscribe► Subscribe
Glaxosmithkline LlcFLOLANepoprostenol sodiumINJECTABLE;INJECTION020444-001Sep 20, 1995► Subscribe► Subscribe
GlaxosmithklineIMITREXsumatriptan succinateTABLET;ORAL020132-003Jun 1, 1995► Subscribe► Subscribe
GlaxosmithklineWELLBUTRINbupropion hydrochlorideTABLET;ORAL018644-002Dec 30, 1985► Subscribe► Subscribe
GlaxosmithklineMALARONEatovaquone; proguanil hydrochlorideTABLET;ORAL021078-001Jul 14, 2000► Subscribe► Subscribe
GlaxosmithklineIMITREXsumatriptanSPRAY;NASAL020626-001Aug 26, 1997► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-006Jan 27, 1999► Subscribe► Subscribe
GlaxosmithklineWELLBUTRINbupropion hydrochlorideTABLET;ORAL018644-001Dec 30, 1985► Subscribe► Subscribe
GlaxosmithklineEPIVIR-HBVlamivudineSOLUTION;ORAL021004-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-001Sep 19, 1997► Subscribe► Subscribe
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Paragraph IV activity for GLAXOSMITHKLINE drugs

Drugname Dosage Strength Tradename Submissiondate
lamotrigineExtended-release Tablets25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mgLAMICTAL XR2/12/2014
nicotine polacrilexGum2 mgNICORETTE1/22/2013
nicotine polacrilexGum4 mgNICORETTE1/22/2013
dutasteride and tamsulosin hydrochlorideCapsule0.5 mg/0.4 mgJALYN10/26/2010
atovaquone and proguanil hydrochlorideTablets62.5 mg/25 mgMALARONE9/14/2010
orlistatCapsules60 mgALLI9/8/2010
lamotrigineOrally Disintegrating Tablets25 mg, 50 mg, 100 mg, and 200 mgLAMICTAL ODT12/21/2009
atovaquoneOral Suspension750 mg/5 mLMEPRON10/20/2009
ropinirole hydrochlorideExtended-release Tablets6 mgREQUIP XL7/22/2009
atovaquone and proguanil hydrochlorideTablets250 mg/100 mgMALARONE4/3/2009
ropinirole hydrochlorideExtended-release Tablets12 mgREQUIP XL2/5/2009
ropinirole hydrochloride*Extended-release Tablets3 mgREQUIP XL1/8/2009
ropinirole hydrochlorideExtended-release Tablets3 mgREQUIP XL1/8/2009
ropinirole hydrochlorideExtended-release Tablets8 mgREQUIP XL11/3/2008
ropinirole hydrochlorideExtended-release Tablets4 mgREQUIP XL10/31/2008
ropinirole hydrochloride Extended-release Tablets2 mgREQUIP XL10/14/2008
lamivudineTablets100 mgEPIVIR-HBV10/31/2007
ranitidine hydrochlorideTablets150 mgZANTAC 15010/30/2007
dutasterideCapsules0.5 mgAVODART10/29/2007
propafenoneExtended-release Capsules325 mgRYTHMOL SR11/7/2006
propafenone hydrochlorideExtended-release Capsules225 mg and 425 mgRYTHMOL SR10/11/2006
sumatriptan succinateInjection6 mg/0.5 mL, 0.5 mL (prefilled syringes)IMITREX5/9/2006
ropinirole hydrochlorideTablets3 mg, 4 mg and 5 mgREQUIP2/4/2005
ropinirole hydrochlorideTablets0.25 mg, 0.5 mg, 1 mg and 2 mgREQUIP12/22/2004
sumatriptan succinateInjection6 mg/0.5 mL, 0.5 mL vialsIMITREX10/25/2004

Non-Orange Book Patents for Glaxosmithkline

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,498,32117.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents► Subscribe
7,132,532Compounds useful in the manufacture of an anti-inflammatory androstane derivative► Subscribe
6,536,427 Inhalation device► Subscribe
7,592,329Crystalline complexes of fluticasone-2-furoate► Subscribe
7,798,368Fluid dispensing device► Subscribe
6,858,593 Anti-inflammatory androstane derivative compositions► Subscribe
6,777,399 Anti-inflammatory androstane derivative compositions► Subscribe
7,361,787Phenethanolamine derivatives for treatment of respiratory diseases► Subscribe
2,006,107,948► Subscribe
9,636,471Medicament dispenser► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Glaxosmithkline Drugs

Country Document Number Estimated Expiration
Austria455540► Subscribe
Portugal1524981► Subscribe
Russian Federation2463065► Subscribe
Singapore10201407864U► Subscribe
Eurasian Patent Organization001484► Subscribe
Colombia5310534► Subscribe
United Kingdom0317374► Subscribe
Yugoslavia3396► Subscribe
Japan2005534392► Subscribe
Australia2010326798► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Glaxosmithkline Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014038Lithuania► SubscribePRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428
14/057Ireland► SubscribePRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
C0042Belgium► SubscribePRODUCT NAME: ZANAMIVIR; NAT. REGISTRATION NO/DATE: 725 IS 380 F 11 19990906; FIRST REGISTRATION: SE 14997 19990209
2011 00026Denmark► SubscribePRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
C/GB01/009United Kingdom► SubscribePRODUCT NAME: AMPRENAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE; REGISTERED: CH 5507201 19990512; CH 5507202 & 5507301 19990512; UK EU/1/00/148/001 20001020; UK EU/1/00/148/002 20001020; UK EU/1/001/148/003 20001020; UK EU/1/00/148/004 20001020
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0140032 00132Estonia► SubscribePRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014
0343Netherlands► Subscribe300343, 20210803, EXPIRES: 20230110
C/GB00/019United Kingdom► SubscribePRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
0694Netherlands► SubscribePRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140430
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Covington
Teva
Chubb
Queensland Health
Cerilliant
Federal Trade Commission
Harvard Business School
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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